- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02770976
Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants
January 25, 2018 updated by: Inha University Hospital
This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants.
The investigators also aim to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal amplitude, work of breathing and comfort of preterm infants.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Incheon, Korea, Republic of, 22332
- Inha University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- preterm infants born before 36 weeks of gestational age
- who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress
- no use of anesthetics or analgetics
Exclusion Criteria:
- with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
- with phrenic nerve palsy or injuries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NAVA
Seven increasing and decreasing NAVA levels (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 3.5, 3.0, 2.5, 2.0, 1.5, 1.0 and 0.5 cmH2O/uV) will applied to 20 preterm infants each for 10 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximum Edi
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
|
mean of recorded maximum electrical activities in the middle 2 min duration out of the total 10 min period
|
the middle 2 minutes duration out of the total interval of 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comfort score
Time Frame: the 5-min point in the total 10-min period
|
calculated score of premature infant pain profile (PIPP) from the recorded video, heart rates and oxygen saturation
|
the 5-min point in the total 10-min period
|
peak inspiratory pressure
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
|
mean of recorded peak inspiratory pressures in the middle 2 min duration out of the total 10 min period
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the middle 2 minutes duration out of the total interval of 10 minutes
|
tidal volume
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
|
mean of recorded expiratory tidal volumes in the middle 2 min duration out of the total 10 min period
|
the middle 2 minutes duration out of the total interval of 10 minutes
|
inspiratory time in excess
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
|
mean of calculated excessive inspiratory times from the calculation ((ventilator pressurization time-neural inspiratory time)/neural inspiratory time) from the middle 2 min duration out of the total 10 min period
|
the middle 2 minutes duration out of the total interval of 10 minutes
|
electrical time product
Time Frame: the middle 2 minutes duration out of the total interval of 10 minutes
|
mean of calculated electrical time product from the middle 2 min duration out of the total 10 min period
|
the middle 2 minutes duration out of the total interval of 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
March 9, 2017
Study Completion (Actual)
March 9, 2017
Study Registration Dates
First Submitted
May 10, 2016
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimate)
May 12, 2016
Study Record Updates
Last Update Posted (Actual)
January 26, 2018
Last Update Submitted That Met QC Criteria
January 25, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAVA-03-INV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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